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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03492710
Other study ID # GC5101F
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date April 30, 2019
Est. completion date April 30, 2019

Study information

Verified date July 2020
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 24 Months to 203 Months
Eligibility Inclusion Criteria:

- Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia

- Subject is willing to comply with all requirements of protocol

- Authorization to access personal health information

Exclusion Criteria:

- Subject has secondary immunodeficiency

- Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG

- Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Immunoglobulin
Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Green Cross Corporation

Outcome

Type Measure Description Time frame Safety issue
Other PK Endpoint (1) Plasma Concentration-Time Curve (PK Parameters of Total IgG) 13 months (12 months of treatment + 1 month of Follow-Up)
Other PK Endpoint (2) Area Under the Curve (PK Parameters of Total IgG) 13 months (12 months of treatment + 1 month of Follow-Up)
Primary Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections) The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess 13 months (12 months of treatment + 1 month of Follow-Up)
Primary Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related 13 months (12 months of treatment + 1 month of Follow-Up)
Secondary Efficacy: Incidence of Infections other than acute serious bacterial infections 13 months (12 months of treatment + 1 month of Follow-Up)
Secondary Safety: The frequency of all AEs that occuring during the study (regardless of the casual relationship) 13 months (12 months of treatment + 1 month of Follow-Up)
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